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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of three different strengths of an investigational product dosed twice a day over 7 days in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | ABT-102 Tablets, 4 mg BID |
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| 2 | Active Comparator | ABT-102 Tablets BID, escalating dose |
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| 3 | Active Comparator | ABT-102 Tablets BID, escalating dose |
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| 4 | Placebo Comparator | Placebo Tablets, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-102 | Drug | BID tablets, 7 days of treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of ABT-102 vs placebo in healthy adults. | 10 days | |
| To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory analyses of Quantitive Thermosensory Testing (Warm Detection Threshold, Cold Detection Threshold, Warm Pain Threshold) done at peripheral and oral sites, will be done for ABT-102 and placebo treated subjects. | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 18101 | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21377273 | Derived | Rowbotham MC, Nothaft W, Duan RW, Wang Y, Faltynek C, McGaraughty S, Chu KL, Svensson P. Oral and cutaneous thermosensory profile of selective TRPV1 inhibition by ABT-102 in a randomized healthy volunteer trial. Pain. 2011 May;152(5):1192-1200. doi: 10.1016/j.pain.2011.01.051. Epub 2011 Mar 4. |
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| ID | Term |
|---|---|
| C528492 | ABT 102 |
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| Placebo |
| Drug |
BID tablets, 7 days of treatment |
|